Online Webinar 2019 - 90 Minutes Live Webinar Handling OOS Test Results and Completing Robust Investigations

Overview
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Session Highlights
FDA requirements for handling OOS/ OOT results
Phase I- Laboratory Phase of Investigations
Phase II a Full Scale Investigation
Concluding an Investigation
Out-of Trend investigations
Common pitfalls during OOS Investigations
Review of recent OOS related citations in Warning Letters
Why Should You Attend
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.
Learning Objectives
Learn the responsibilities of analysts and supervisors
Listen to what the FDA looks for in terms of human errors
Describe when a full investigation should be triggered
Describe the frequency for re-testing and re-sampling
Learn how to implement the corrective and preventive action plans (CAPA)
Who Will Benefit
QA managers and personnel
Analysts and lab managers
CAPA management
Regulatory affairs
Training departments
Faculty: Danielle DeLucy Owner, ASA Training and Consulting, LLC
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.